Phase 4 N=12 Randomized Basic Science

Post-treatment Effects of Ivermectin (IVM) or Diethylcarbamazine (DEC) in Loiasis

Loiasis

Bottom Line

View on ClinicalTrials.gov: NCT01593722 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2016

Primary outcome: Primary: The Peak % of Baseline Eosinophil Count Measured During the First 7 Days Post-treatment. — 196; 165 percentage of baseline — p=0.68

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Diethylcarbamazine (Drug); Ivermectin (Drug)
Age: Adult · 20+ yrs
Sex: All
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion: Aug 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY The Peak % of Baseline Eosinophil Count Measured During the First 7 Days Post-treatment.	196; 165	0.68
SECONDARY The Frequency of Adverse Events	115; 103	—
SECONDARY Eosinophil Activation	21.5; 21.5; 1.7; 1.5	—
SECONDARY Proportion of Subjects Who Clear Microfilaremia	3; 0	—

Summary

Background: * Loa loa is a small worm that infects people in West and Central Africa. It is spread by the bite of a fly. Adult worms live under the skin and can cause swelling in the arms, legs, and face. Some people have more serious infections in the heart, kidneys, or brain. Most people with Loa loa infection have no symptoms at all. The standard treatment for Loa loa infection is a medicine called diethylcarbamazine (DEC). Some people have bad reactions to DEC, including itching, muscle pains, and in severe cases coma and death. * Another drug, ivermectin, is used in mass drug treatment programs to prevent the spread of worm infections that cause blindness and massive swelling (elephantiasis). However, people who also have Loa loa have had serious bad reactions to ivermectin. Researchers want to study both DEC and ivermectin to find out why these reactions occur. If they can be prevented, mass drug treatment programs will be able to be used in areas in Africa where Loa loa exists. Objectives: - To study the side effects of DEC and ivermectin treatment for Loa loa infection. Eligibility: - Individuals who live in 4 villages in Cameroon where Loa loa infection is known to exist, who are between 20 and 60 years of age, not pregnant or breastfeeding and have a low level of Loa loa parasites in the blood, but are otherwise healthy. Design: * Participants will be screened with a physical exam and medical history. Blood samples will be collected to check for Loa loa infection. Participants will also have an eye exam and provide skin samples to check for other worm infections that may interfere with the study treatment. * Participants will be admitted to the hospital for 4 days (during and after the treatment). They will receive a single dose of either DEC or ivermectin. * After treatment, regular blood samples will be collected. Participants will be asked questions about how they feel after treatment. Physical exams will be performed. If side effects develop, participants will be treated at the hospital. * After leaving the hospital, participants will have followup visits. These visits will happen on days 5, 7, 9, and 14 after receiving the study medicine. They will involve a short physical exam and collection of blood samples. * At the end of the study, participants will be offered a full 21-day DEC treatment to cure the Loa loa infection.

Eligibility Criteria

INCLUSION CRITERIA (SCREENING):

A subject will be eligible for participation in the screening portion of this protocol if all of the following criteria apply:

male or non-pregnant and not breastfeeding female subjects,
age 20-60 years (per participant self-report)
resident of Akonolinga
Loa microfilaremia from 20 to 5000 mf/mL from the prior screening in the village or did not participate in the prior screening
consent to a blood draw to screen for infection with Loa loa
must be willing to have blood samples stored

EXCLUSION CRITERIA (SCREENING):

A subject will not be eligible for participation in the screening portion of this study if any of the following conditions apply:

Known to be pregnant (by history) or breastfeeding
Chronic medical conditions, including but not limited to diabetes, renal or hepatic insufficiency, immunodeficiency, psychiatric disorder, seizure, that in the investigators judgments are deemed to be clinically significant
History of hypersensitivity reaction to DEC or IVM

INCLUSION CRITERIA (INTERVENTIONAL STUDY):

A subject will be eligible for participation in the interventional portion of the study only if all of the following additional inclusion criteria apply:

Loa loa microfilaremia between 20 and 2,000 mf/mL blood drawn between 11:30 am and 2:30 pm measured within 30 days prior to the baseline visit
The subject agrees to storage of samples for study

EXCLUSION CRITERIA (INTERVENTIONAL STUDY):

A subject will not be eligible to participate in the interventional portion of the study if any of the following conditions are fulfilled at the time of enrollment:

Pregnancy (by serum or urine beta-HCG) or breastfeeding
Chronic kidney or liver disease
Hgb < 10 gm/dL
Filarial infection other than Loa loa or M. perstans (O. volvulus, or W. bancrofti)
Use of DEC or IVM within the past 6 months
Use of immunosuppressive therapies, including steroids, within the past month
Any condition that in the investigator s opinion places the subject at undue risk by participating in the study

EXCLUSION OF CHILDREN AND PREGNANT WOMEN:

Pregnant women and children (the age of consent in Cameroon is 20 years of age) will be excluded from this study since it involves administration of medications contraindicated in pregnancy and more than minimal risk with no prospect of direct benefit, respectively.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01593722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.